MGB Alert Pneumocystis Primer Mix 48rxn M800573

GUDID 03661540950056

MGB Alert® Pneumocystis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Pneumocystis jirovecii. The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 156 bp nucleic acid sequence from the multi-copy mitochondrial large subunit rRNA (mtLSU) gene of Pneumocystis jirovecii.

ELITECH GROUP INC.

Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT) Pneumocystis jirovecii nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID03661540950056
NIH Device Record Key87845d31-a119-40f3-b665-a0f934ee6c6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMGB Alert Pneumocystis Primer Mix 48rxn
Version Model NumberM800573
Catalog NumberM800573
Company DUNS079696864
Company NameELITECH GROUP INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com
Phone8004532725
Emailmdx@elitechgroup.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103661540950056 [Primary]
GS103661540950056 [Primary]
GS103661540950056 [Primary]
GS103661540950056 [Primary]
GS103661540950056 [Primary]
GS103661540950056 [Primary]
GS103661540950056 [Primary]
GS103661540950056 [Primary]
GS103661540950056 [Primary]
GS103661540950056 [Primary]
GS103661540950056 [Primary]
GS103661540950056 [Primary]
GS103661540950056 [Primary]
GS103661540950056 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte
MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

Devices Manufactured by ELITECH GROUP INC.

03661540950032 - MGB Alert Internal Control Set IC2-BH 48 rxn2020-09-23 The MGB Alert Internal Control Set IC2-BH consists of reagents intended for use as an unassayed internal extraction and amplific
03661540950124 - MGB Alert Internal Control Set IC2-B, 09N38-0012020-09-23 The MGB Alert Internal Control Set IC2-B consists of reagents intended for use as an unassayed internal extraction and amplifica
03661540950155 - MGB Alert Internal Control Set IC1, 09N39-0012020-09-23 The MGB Alert Internal Control Set IC1 consists of reagents intended for use as an unassayed internal extraction and amplificati
03661540950186 - MGB Alert Internal Control Set IC1-A, 09N40-0012020-09-23 The MGB Alert Internal Control Set IC1-A consists of reagents intended for use as an unassayed internal extraction and amplifica
03661540950247 - MGB Alert Internal Control Set IC2-T2020-09-23 The MGB Alert Internal Control Set IC2-T consists of reagents intended for use as an unassayed internal extraction and amplifica
03661540950254 - MGB Alert Internal Control Set IC2-T, 09N42-0012020-09-23 The MGB Alert Internal Control Set IC2-T consists of reagents intended for use as an unassayed internal extraction and amplifica
03661540950278 - MGB Alert Platinum Master Mix-48 rxn2020-09-23 The MGB Alert Platinum Master Mix is intended for use in the development of laboratory assays which target DNA analytes using re
03661540950322 - MGB Alert Internal Control Set IC2-8 48 rxn2020-09-23 The MGB Alert Internal Control Set IC2-8 consists of reagents intended for use as an unassayed internal extraction and amplifica

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.